BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY ID

    MDR report key: 1192564 · Received October 10, 2008

    Report

    Report Number
    1034569-2008-00510
    Event Type
    Malfunction
    Date Received
    October 10, 2008
    Date of Event
    September 25, 2008
    Report Date
    October 9, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REACTIVITY OF THE E ANTIGEN WAS CONFIRED ON RETENTION CRRID LOT ID 103. THE CUSTOMER DID NOT RETURN PRODUCT OR SAMPLE. IT IS NOT POSSIBLE TO RULE OUT THE SAMPLE AS A CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON THE GALILEO USING CAPTURE-R READY ID (CRRID), ON A PATIENT SAMPLE THAT TESTED POSITIVE FOR ANTIBODY SCREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY ID REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. ID 103

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR